FDA Announces New Drug Safety Initiative

The U.S. Food and Drug Administration (FDA) launched a new program to make drug safety information available in an easily accessible format to make safety information available about the medicines consumers are using. Included in the announcement: drug safety information in a new web location; Draft Guidance: FDA’s “Drug Watch” for Emerging Drug Safety Information; Manual of Policies and Procedures: Drug Safety Oversight Board; Questions and Answers on FDA’s New Drug Safety Initiative; and questions and answers on the Initiative. (Note: There is a 90-day comment period on the agency’s draft guidance document).